Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest
Launched by UNIVERSITY HOSPITAL, TOULOUSE · Sep 24, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial aims to find out how well a special type of brain imaging called MRI (which includes structural MRI, functional MRI, and contrast-enhanced MRI) can predict how well a person will recover after they have experienced a cardiac arrest and been in a coma. Researchers will compare the results from this advanced imaging with standard methods, such as clinical examinations and blood tests, to see which is better at predicting recovery after six months.
To be eligible for this trial, participants need to be adults (18 years or older) who are in a coma after a cardiac arrest, showing very limited responses to stimuli. They also need to remain unconscious for at least 72 hours after their sedation has stopped. It’s important that a legal representative gives consent for them to participate. Unfortunately, individuals with certain conditions, like brain death or severe kidney issues, or those who are pregnant, cannot join the study. If someone participates, they can expect to undergo MRI scans as part of the assessment, which will help researchers understand more about recovery outcomes after cardiac arrest.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients (male or female ≥ 18 years).
- • Coma, as indicated by a Glasgow Coma Scale (GCS) ≤ 8 (motor score ≤ 2) immediately after CA resuscitation and before sedation onset.
- • Persisting unconsciousness, defined as the inability to obey verbal commands, after at least 72 hours from complete withdrawal of sedation in normothermia conditions.
- • Written informed consent from patient's legal representative.
- • Affiliation or beneficiary to the French social security system.
- Exclusion Criteria:
- • Brain death.
- • Coma explained by other cause than CA.
- • Likely poor neurological outcome based on early predictors, following ERC-ESCIM 2021 recommendations. In a comatose patient with GCS motor score ≤ 3 at ≥ 72 h from ROSC, in the absence of confounders, the identification of at least two of the following: bilaterally absent pupillary light and corneal reflexes at ≥ 72h, bilaterally absent N20 SSEP ≥ 24h; neuron-specific enolase (NSE) \> 60 μg/l at 48h and/or 72h, status myoclonus ≤72h.
- • Decision of WLST previous to patient recruitment, based on early predictors of poor neurological outcome, age, co-morbidity, general organ function and patient's preferences.
- • Life expectancy shorter than 6 months based on pre-morbid conditions.
- • Former neurological functional disability (mRS \> 2 before CA).
- • MRI contraindication: medical material not MRI compatible, claustrophobia
- • Known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium
- • Severe kidney failure defined as a KDIGO score \> 3 (glomerular filtration rate \< 30 ml/min/1.73 m2 or renal replacement therapy).
- • Hemodynamic shock or severe respiratory failure precluding patient's transport and MRI scanning.
- • Pregnancy or nursing woman.
- • Patient under juridical protection.
About University Hospital, Toulouse
The University Hospital of Toulouse is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific inquiry with comprehensive clinical services. Its multidisciplinary team of healthcare professionals collaborates with renowned researchers to facilitate pioneering studies across various medical fields, aiming to enhance treatment options and improve patient outcomes. As a prominent institution in the region, the University Hospital of Toulouse is committed to fostering an environment of excellence in both education and research within the healthcare community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Stein SILVA, MD PhD
Principal Investigator
University Hospital of Toulouse
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported